MelasmaPhase 2NCT06013540
Comparison Of Efficacy Of Combination Of TAM Formula Vs Kligman Formula For Melasma.
A Phase 2 study testing TAM formula (hydroquinone 2%, tretinoin 0.05% and 5% vitamin C) and Kligman formula (hydroquinone 4%, fluocinolone acetonide 0.01% and tretinoin 0.05%) in people with Melasma, run by Jinnah Postgraduate Medical Centre at 1 site in Pakistan.
Trial summary
This study would offer the participants about the knowledge of these formula in the treatment of melasma and help the investigators in incorporating and updating the management protocols in medical practice. Read more about this study
- Who is it for?
- Ages 25 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Melasma
- What is being tested?
- TAM formula (hydroquinone 2%, tretinoin 0.05% and 5% vitamin C) and Kligman formula (hydroquinone 4%, fluocinolone acetonide 0.01% and tretinoin 0.05%)
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 122 participants
- Where
- 1 sitePakistan
- Study dates
- 1 Aug 2022to 30 Aug 2023
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 25 to 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Patients between 25-65 years of age, either gender having melasma for over one month will be included in the study
Who cannot join
- Pregnancy, breastfeeding, taking birth control pills or plans to become pregnant during the study
- History of cutaneous photosensitization, porphyria, and hypersensitivity to porphyrins or photodermatosis
- History of skin pathology or condition that could interfere with the evaluation or requires the use of interfering topical or systemic therapy
- History of uncorrected coagulation defect or is currently using anti-coagulation medication (including but not limited to heavy aspirin therapy)
- History of sensitivity to hydroquinone or Retin-A
- History of evidence of a compromised immune system or hepatitis
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Comparison Of The Efficacy Of Combination Of TAM Formula Versus Kligman Formula For Melasma At Tertiary Care Hospital,Karachi.
This study would offer the participants about the knowledge of these formula in the treatment of melasma and help the investigators in incorporating and updating the management protocols in medical practice.
- Conditions
- Melasma
- Being tested
- TAM formula (hydroquinone 2%, tretinoin 0.05% and 5% vitamin C), Kligman formula (hydroquinone 4%, fluocinolone acetonide 0.01% and tretinoin 0.05%)
- Medical subject headings
- Melanosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
TAM formula (hydroquinone 2%, tretinoin 0.05% and 5% vitamin C)Combination product
TAM formula (hydroquinone 2%, tretinoin 0.05% and 5% vitamin C)
Kligman formula (hydroquinone 4%, fluocinolone acetonide 0.01% and tretinoin 0.05%)Combination product
Kligman formula (hydroquinone 4%, fluocinolone acetonide 0.01% and tretinoin 0.05%)
| Study group | Role | What they receive |
|---|---|---|
| Group A TAM formula (hydroquinone 2%, tretinoin 0.05% and 5% vitamin C) | Experimental | Not described Receives: Combination Product: TAM formula (hydroquinone 2%, tretinoin 0.05% and 5% vitamin C) |
| Group B Kligman formula (hydroquinone 4%, fluocinolone acetonide 0.01% and tretinoin 0.05%) | Experimental | Not described Receives: Combination Product: Kligman formula (hydroquinone 4%, fluocinolone acetonide 0.01% and tretinoin 0.05%) |
What is being measured
The primary outcome is the main question the study is designed to answer.
EFFICACY OF COMBINATION OF TAM FORMULA VERSUS KLIGMAN FORMULA IN TREATMENT OF MELASMA
Efficacy will be assessed by using Modified MASI(Melasma Area and Severity Index)In MASI scoring the "area of involvement" is calculated from 0 to 6 while the intensity and homogeneity of pigmentation are scored from 0 to 4 only. (Melasma Area Severity Index)
Measured: Efficacy will be assesed upto 2 months.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Aug 2023
- Study start1 Aug 2022
- Primary completion1 Dec 2022
- Study completion30 Aug 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for MelasmaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 122 participants (actual)
Sponsor and investigators
- Lead sponsor
- Jinnah Postgraduate Medical Centre
- Sponsor type
- Other government
- Responsible party
- Principal investigator, Dr Khadijah Asadullah, Jinnah Postgraduate Medical Centre
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06013540
- Sponsor's protocol ID
- NO.F2-81/2022-GENL/255/JPMC
- Status last verified
- Aug 2023
- First submitted
- 22 Mar 2023
- Last updated
- 28 Aug 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 28 Aug 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison Of The Efficacy Of Combination Of TAM Formula Versus Kligman Formula For Melasma At Tertiary Care Hospital,Karachi.
- ClinicalTrials.gov ID
- NCT06013540
- Acronym / sponsor ID
- NO.F2-81/2022-GENL/255/JPMC
- Conditions
- Melasma
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 122 participants (actual)
- Lead sponsor
- Jinnah Postgraduate Medical CentreOther government
- Study start
- 1 Aug 2022 (actual)
- Primary completion
- 1 Dec 2022 (actual)
- Study completion
- 30 Aug 2023 (estimated)
- First posted
- 28 Aug 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This study would offer the participants about the knowledge of these formula in the treatment of melasma and help the investigators in incorporating and updating the management protocols in medical practice.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Group A TAM formula (hydroquinone 2%, tretinoin 0.05% and 5% vitamin C) | Experimental | Combination Product: TAM formula (hydroquinone 2%, tretinoin 0.05% and 5% vitamin C) |
| Group B Kligman formula (hydroquinone 4%, fluocinolone acetonide 0.01% and tretinoin 0.05%) | Experimental | Combination Product: Kligman formula (hydroquinone 4%, fluocinolone acetonide 0.01% and tretinoin 0.05%) |
Who may qualify
- Ages
- 25 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Patients between 25-65 years of age, either gender having melasma for over one month will be included in the study
Key exclusion criteria (6 listed)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| TAM formula (hydroquinone 2%, tretinoin 0.05% and 5% vitamin C)TAM formula (hydroquinone 2%, tretinoin 0.05% and 5% vitamin C) | Combination product | Group A TAM formula (hydroquinone 2%, tretinoin 0.05% and 5% vitamin C) |
| Kligman formula (hydroquinone 4%, fluocinolone acetonide 0.01% and tretinoin 0.05%)Kligman formula (hydroquinone 4%, fluocinolone acetonide 0.01% and tretinoin 0.05%) | Combination product | Group B Kligman formula (hydroquinone 4%, fluocinolone acetonide 0.01% and tretinoin 0.05%) |
Primary outcome
EFFICACY OF COMBINATION OF TAM FORMULA VERSUS KLIGMAN FORMULA IN TREATMENT OF MELASMA
Time frame: Efficacy will be assesed upto 2 months.
Efficacy will be assessed by using Modified MASI(Melasma Area and Severity Index)In MASI scoring the "area of involvement" is calculated from 0 to 6 while the intensity and homogeneity of pigmentation are scored from 0 to 4 only. (Melasma Area Severity Index)
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Aug 2023.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing TAM formula (hydroquinone 2%, tretinoin 0.05% and 5% vitamin C) and Kligman formula (hydroquinone 4%, fluocinolone acetonide 0.01% and tretinoin 0.05%) in people with Melasma, run by Jinnah Postgraduate Medical Centre at 1 site in Pakistan.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 28 Aug 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Pakistan. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
EFFICACY OF COMBINATION OF TAM FORMULA VERSUS KLIGMAN FORMULA IN TREATMENT OF MELASMA (time frame: Efficacy will be assesed upto 2 months.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Aug 2023.